Usual Adult Dose for Otitis Media

Ciprofloxacin 0.75 mg-fluocinolone 0.0625 mg (1 single-dose vial) instilled into the affected ear canal 2 times a day (every 12 hours)

• Duration of therapy: 7 days

Comments:

• The vial should be warmed in the hands for 1 to 2 minutes prior to administration to avoid dizziness associated with instillation of a cold solution into the ear canal.
• Once instilled, the tragus should be pumped inward 4 times, then the patient should remain in the position for at least 1 minute.

Use: Treatment of acute otitis media with tympanostomy tubes (AOMT) due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and/or Streptococcus pneumoniae

Usual Pediatric Dose for Otitis Media

6 months and older: Ciprofloxacin 0.75 mg-fluocinolone 0.0625 mg (1 single-dose vial) instilled into the affected ear canal 2 times a day (every 12 hours)

• Duration of therapy: 7 days

Comments:

• The vial should be warmed in the hands for 1 to 2 minutes prior to administration to avoid dizziness associated with instillation of a cold solution into the ear canal.
• Once instilled, the tragus should be pumped inward 4 times, then the patient should remain in the position for at least 1 minute.

Use: Treatment of AOMT due to H influenzae, M catarrhalis, P aeruginosa, S aureus, and/or S pneumoniae

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to either active component, other corticosteroids, other quinolones, or any of the ingredients
• Viral infections of the ear canal, including fungal otic, herpes simplex, and varicella infections

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Patients should lie with the affected ear upward before administration.
• If both ears are affected, the administration procedure should be repeated for the opposite ear.
• Use of additional otic agents should be given

Storage requirements:

• This drug should be protected from light by being kept inside the foil pouch until ready to use.
• Unused vials should be discarded 7 days after opening the pouch.

General:

• Each vial delivers 0.25 mL, which is equivalent to 0.75 mg of ciprofloxacin and 0.0625 mg fluocinolone. Vials are intended for single-use only and should be discarded after use.
• Limitations of use: This drug is indicated for otic use only. It is not indicated for injection, inhalation, ophthalmic, or oral use.

Patient advice:

• Patients should be told that this drug is for otic use only.
• Patients should be instructed to wash their hands before and after applying this drug.
• Caution patients to warm the vial in the hands for 1 to 2 minutes to prevent dizziness during administration.
• Patients should be encouraged to avoid missing doses and complete the entire course of therapy.
• Patients should be advised to immediately report any signs/symptoms of hypersensitivity reactions.